tbuckley/cabot-search huggingface dataset:
CemiplimAb-rwlc survivorship and epidemiology (CASE): A prospective study of safety and efficacy of cemiplimab in patients with advanced basal cell carcinoma in a real-world setting.
Authors: Soo J Park, David Ellison, Ryan Michael Weight, Jade Homsi, Guilherme Rabinowits, Emily S. Ruiz, John Strasswimmer, Josh David Simmons, Timothy J. Panella, Ruben GW Quek, Gregory Ursino, Jean-Francois Pouliot, Nikhil I. Khushalani
Journal: Journal of Clinical Oncology (2023)

TPS9614 Background: Basal cell carcinoma (BCC) is the most common form of non-melanoma skin cancer in the United States. Surgical excision is the standard treatment, with &lt; 1% of cases progressing to locally advanced or metastatic disease. Hedgehog pathway inhibitors (HHIs) are the first-line therapy for advanced BCC (aBCC); the US Food and Drug Administration and European Medicines Agency have approved the use of cemiplimab (a programmed cell death-1 inhibitor) in advanced BCC (aBCC) patients previously treated with (or are inappropriate for) HHI. Limited real-world data exist on the clinical characteristics, disease management and progression, and survivorship of patients with aBCC. The ongoing C.A.S.E. study aims to evaluate the efficacy, safety, disease evolution, survivorship, and patient reported outcomes (PRO) in patients treated with cemiplimab in the real-world setting. Methods: This trial in progress (NCT03836105) aims to describe the effectiveness and safety of cemiplimab 350 mg administered every 3 weeks for treatment of patients with aBCC in real-world clinical settings. Up to 100 adult patients with aBCC who are prescribed commercially available cemiplimab from ~65 study sites in the United States will be included. The duration of follow-up will be 24 months. Endpoints for this study relate to real-world efficacy, including overall survival; progression-free survival; objective response rate, (partial or complete response); and disease control rate, defined as the percentage who do not progress for ≥ 6 months; Time to response, duration of response, time to treatment failure, and disease-specific death will also be assessed. Real-world safety outcomes will also be captured, including immune-related adverse events, infusion-related reactions, and serious adverse events. Patient selection criteria and treatment patterns will be analyzed using descriptive statistics. This study also aims to describe the patient experience of real-world treatment with cemiplimab. PROs including global quality of life, functioning, and symptoms will be captured at baseline and follow-up visits via the EORTC QLQ-C30 and the Skin Care Index. Recruitment for this trial is ongoing. Clinical trial information: NCT03836105 .
Participation in phase I oncology trials by minorities: Survival and compliance data.
Authors: Bruno R. Bastos, Mukesh Roy, Guilherme Rabinowits, Muni B. Rubens
Journal: Journal of Clinical Oncology (2023)

e18628 Background: Since 1993, the National Institutes of Health requires all clinical trials to include women and minority participation in clinical research. Despite this initiative, Minority (M) participation in Phase I Oncology clinical trials is subpar; historical data indicate a participation of 79% Caucasian (C) versus 21% (M) in Phase I clinical trials. The purpose of this study is to compare demographics, survival, and compliance data between (C) versus (M) patients participating in Phase I Oncology clinical trials in our Cancer Institute. Methods: We performed a retrospective analysis in all patients enrolled in phase I clinical trials in our institution from April 2019 until October 2022. This information was obtained via OnCore. Data was abstracted manually and entered in a spreadsheet (Excel). Data variables include race, gender, withdrawal of consent, and lost follow-up. Statistical plan was determined by our statistical team with data analysis to be performed with statistical software to generate Kaplan Meyer (KM) Survival Curve. Results: A total of 99 patients were identified. 61.5% were (C) and 38.4 % were (M). (M) consisted of Hispanic (81%), African American (18%) and Asian (1%). Female Gender on (C) were 57.4% and 55.3% on (M). Lost follow-up was 2.8% on (C) and 5.9% on (M). Withdrawal of consent was 5.6% on (C) and 0% on M. The (KM) curve revealed non statistically significant difference in survival p = 0.7316. Conclusions: In our analysis, we found statistically similar (KM) survival curves for (C) and (M) participating in Phase I clinical trials (p = 0.7316). We found a significant higher participation of (M) patients in our institute than historical data. There was no significant difference in withdrawal of consent between (C) and (M) and no difference on lost follow-up. We plan to identify patterns of success in enrolling minorities in our site and validate a questionnaire to screen patients for Phase I clinical trials with the goal to minimize perception bias and barriers for enrollment of (M) in Phase I studies.
Teaching how to navigate difficult conversations: A combined palliative care–oncology didactic simulation intervention for hematology/oncology fellows.
Authors: Megan Dupuis, Katherine Jean Walsh, Rajiv Agarwal
Journal: Journal of Clinical Oncology (2023)

11028 Background: ASCO strongly endorses the integration of palliative care to improve patient outcomes and support patients in their cancer trajectories. Developing core palliative care skills for trainees is therefore essential, with few ACGME approved pilot programs offering combined fellowship training. Our institution’s Heme/Onc fellows reported a need for additional education in leading difficult conversations. Methods: We piloted a didactic simulation (sim) session for each fellowship class, led by a faculty member who is dual board-certified in Medical Oncology and Hospice/Palliative Medicine. Trainees received a lecture on validated communication tools and oncology-specific language to help navigate difficult conversations. Trainees then role-played in small groups using sample cases, with Heme/Onc faculty supervision and real-time feedback, followed by class reflection. Pre- and post-sim surveys were electronically administered to assess knowledge of communication tools and comfort in discussing difficult topics. Comfort questions were scored on a 5-point Likert Scale, using student t-tests to detect differences pre- and post-sim, and ANOVA to compare responses among classes. Results: A total of 16/21 (76.2%) fellows completed both pre- and post-sim surveys. Knowledge of communication tools increased from 21.9% pre-sim to 79.7% post-sim. Comfort significantly increased for explaining palliative-intent chemotherapy, hospice, and discussing an uncertain prognosis (Table). There was a significant difference among classes pre-sim for addressing negative emotions (mean comfort level: 1 st years 2.8, 2 nd years 3.4, 3 rd years 3.83; p=0.046) and for discussing an uncertain prognosis (mean comfort level: 1 st years 2.6, 2 nd years 3.6, 3 rd years 3.83; p=0.043); however, these interclass discrepancies were eliminated post-sim. Overall, fellows reported that the sim sessions were effective for developing their knowledge and comfort in having difficult conversations. Conclusions: A novel sim intervention led by a physician who is dual board-certified in palliative care and medical oncology improves trainee competency with navigating difficult conversations. Analysis of the intervention’s durability of response and iterative refinement of its curriculum are ongoing. [Table: see text]
Induction and concomitant chemoradiotherapy (CCRT) using modified TPF (docetaxel, cisplatin and 5-FU) for the patients with stage IVB advanced head and neck cancer.
Authors: Kiyoto Shiga, Katsunori Katagiri, Daisuke Saitoh, Shin-ichi Oikawa, Kodai Tuchida, Takahiro Kusaka, Yu Ohashi
Journal: Journal of Clinical Oncology (2023)

e18031 Background: Efficacy of TPF chemotherapy has been reported mainly in the induction chemotherapy (IC) for head and neck squamous cell carcinoma (HNSCC) so far. The aim of this study was to determine the safety and efficacy of CCRT using modified TPF protocol in patients with Stage IVB HNSCC. Methods: Patients with previously untreated, histologically proven Stage IVB disease of the head and neck were eligible for the study. Twenty-six patients of the HNSCC were enrolled between January 2018 and October 2021 including 6 HPV(-) oropharyngeal, 5 hypopharyngeal, 4 ethmoid, 4 maxillary, 2 primary unknown and 5 other cancers. There were 14 T4b and 13 N3b tumors. CCRT consisted of radiotherapy administered once daily to a total dose of 70 Gy, concomitant with 120-hour infusions of 5-FU (600 mg/m 2 /day), Docetaxel (50 mg/m 2 , day 2) and Cisplatin (60 mg/m 2 , day 2) given during first and fifth week of radiotherapy. These drug doses were determined from the results of our former phase I study to assess the dose limiting toxicity of this protocol. Median follow-up period was 21 months. Results: Eight patients with Stage IVB HNSCC underwent IC and CCRT with this modified TPF protocol. Eight patients underwent CCRT using 2 courses of modified TPF. Five patients underwent CCRT with CDDP, three of them underwent arterial infusion of CDDP by super-selective angiography via external carotid artery. Three other patients underwent CCRT using other protocols and two underwent RT without chemotherapy. Bone marrow suppression was the most common adverse event observed through this study. Although all patients showed dermatitis and mucositis at any grade, other grade 3 or 4 adverse events in these patients were not common. Complete response was obtained in all patients except four patients. The progression-free and over-all survival rates at 24 months of all the patients with Stage IVB HNSCC in our series were 53.4% and 59.1%, respectively. Those of the patients who underwent IC and CCRT with modified TPF protocol were 58.3% and 80.0%, respectively and significantly better than those of the patients with other treatment protocols. Conclusions: Our results suggested that IC followed by CCRT using modified TPF was feasible and very effective in patients with Stage IVB HNSCC.
Novel MRI scoring system to assess osseous malignancy in patients with soft tissue sarcoma following radiotherapy.
Authors: Gayathri Vijayakumar, Conor M. Jones, Stephen Supple, John R. Meyer, Alan T. Blank
Journal: Journal of Clinical Oncology (2023)

11561 Background: Although radiotherapy is an important component of STS management, radiation induced changes such as radiation osteitis are commonly identified on magnetic resonance imaging (MRI). These imaging findings may be concerning for malignancy and sometimes require biopsy for investigation. This study proposes a novel MRI scoring system to assess osseous lesions and predict potential for malignancy based on MRI score in STS patients who received radiotherapy. Methods: The MRI score consisted of 3 parameters: morphology, signal intensity, and progression. Interobserver reliability between the total score of MRI examinations scored by two senior musculoskeletal radiologists were analyzed with Cohen’s kappa coefficient. Receiver operating curve (ROC) analysis was performed to determine a predictive MRI score for malignancy. Results: 156 MRI’s from 30 STS patients who received radiotherapy were retrospectively reviewed. Two (6.7%) patients developed regional osseous metastasis identified on MRI. The kappa coefficient of the scoring system was 0.785 demonstrating substantial interobserver agreement (p&lt;0.001). ROC analysis demonstrated that the optimal cut-off value for malignant lesion on MRI was 5.5 (area under the curve 0.998 (95% CI 0.993-1.000) p&lt;0.001). Conclusions: This novel MRI scoring system recommends lesions with a score of six and above to be biopsied to distinguish if malignancy is present. We believe this scoring system can be utilized by multidisciplinary care teams to guide clinical recommendations for patients with STS and MRI findings concerning for malignancy versus radiation induced changes.[Table: see text]
Dacomitinib for patients with non-small cell lung cancer harboring uncommon epidermal growth factor receptor mutations: Do mutation patterns matter?
Authors: Hong-Shuai Li, Siyu Lei, Haiyan Xu, Puyuan Xing, Xiang Yan, Yan Wang
Journal: Journal of Clinical Oncology (2023)

9106 Background: Previous evidence has revealed the potential efficacy of dacomitinib in patients with advanced non-small cell lung cancer (NSCLC) carrying uncommon epidermal growth factor receptor ( EGFR) mutations, but it remains unknown whether there are differences in its efficacy for different combination patterns of these uncommon mutations. Methods: The AFANDA cohort, an ambispective cohort including 121 NSCLC patients with uncommon EGFR mutations admitted from two tertiary hospitals in China, was employed for exploration. Meanwhile, a cohort of 63 patients with common mutations was included for comparison. Objective response rate (ORR), progression-free survival (PFS), and adverse events (AEs) were assessed between groups. Results: A total of 133 patients with advanced or recurrent NSCLC that received dacomitinib were eligible for analysis. Baseline characteristics were balanced between subgroups. A significant difference was observed between patients with common mutations (C group, n = 63), common mutation plus uncommon mutations (C+U group, n = 24), and uncommon mutations (U group, n = 46) regarding to PFS (mPFS: 7.07, 8.17, and 11.97 months; p = 0.026). Moreover, the highest ORR and DCR of the U group were observed among subgroups, although the differences were not statistically significant (ORR, 40.4%, 40.9%, and 61.4%; p = 0.085; DCR, 78.9%, 72.7%, 90.9%; p = 0.134). Furthermore, the multivariate analysis revealed that the mutation pattern was an independent prognostic indicator of PFS ( p = 0.049), with the C+U group having the highest risk of progression (HR [hazard ratio]: 1.438, 95% CI [confidence interval]: 0.818-2.528) while the U group having the lowest one (HR: 0.666, 95% CI: 0.409-1.084). For toxicity analysis, no significant difference was observed regarding grade 3-4 AEs among subgroups (12.7%, 8.3%, 13.0%; p = 0.827). The drug resistance analysis did not reveal a significant difference concerning the secondary T790M mutation rate (26.3%, 0%, 13.3%; p = 0.331). Conclusions: Dacomitinib demonstrated different therapeutic efficacy for patients with NSCLC harboring different combination patterns of uncommon EGFR mutation, which should be considered in clinical trials' design and clinical application. [Table: see text]
Incomplete HPV vaccination among individuals aged 27-45 years in the United States: A mixed effect analysis of individual and contextual factors.
Authors: Victor Adekanmbi, Fangjian Guo, Christine Hsu, Yong-Fang Kuo, Abbey Berenson
Journal: Journal of Clinical Oncology (2023)

10546 Background: In the United States, the Human papillomavirus (HPV) vaccine is approved for use up to age 45. Incomplete HPV vaccination rates among those over age 26, however, remain high. The aim of this study was to examine the independent effects of individual- and neighborhood-level factors on incomplete HPV vaccine series in the United States (US) among those aged 27-45 years. Methods: This retrospective cohort study used administrative data from Optum’s Clinformatics DataMart Database to identify individuals aged 27-45 years who received 1 or more doses of HPV vaccine between July 2019 and June 2022. Multilevel multivariable logistic regression models were applied to the data on 7,662 individuals aged 27-45 years who were fully vaccinated against HPV or not, nested within 3839 neighborhoods across the US. Results: More than half of the participants in this study (52.93%) were not completely vaccinated against HPV. About 64% of the eligible participants aged 27-30 years did not complete their HPV vaccine series. After adjusting for all other covariates in the final model, being older than 30 years old decreased the odds of incomplete HPV vaccine series. Participants living in neighborhoods of South region of the US had enhanced odds of incomplete HPV vaccine series compared to those residing in Northeast region (aOR 1.21; 95% CrI 1.03–1.42). There was significant clustering of incomplete HPV vaccine series at the neighborhood level. Conclusions: This study revealed that individual- and neighborhood-level factors significantly influence HPV vaccination incompleteness in the US. Interventions to improve HPV vaccination uptake and completion should take into consideration both individual- and contextual-level characteristics during design, planning and implementation of policies and programs to improve HPV vaccination coverage and completion in the US and other similar countries. Acknowledgement Dr. Adekanmbi is supported by a research career development award (K12HD052023: Building Interdisciplinary Research Careers in Women’s Health Program-BIRCWH; Berenson, PI) from the National Institutes of Health/Office of the Director (OD), National Institute of Allergy and Infectious Diseases (NIAID), and Eunice Kennedy Shriver National Institute of Child Health &amp; Human Development (NICHD). Dr. Guo is currently supported by an award (K07CA222343) from the National Institutes of Health, National Cancer Institute (NIH/NCI). Dr. Berenson is supported by an award (PP200048) from the Cancer Prevention and Research Institute of Texas (CPRIT). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or CPRIT. Conflict of Interest: All authors report no conflicts of interest.
Treatment patterns and outcomes of diffuse alveolar hemorrhage: Findings from a single-center retrospective study.
Authors: McKenna Butler, Aubrey Defayette, Jordan Pleskow, Alyssa Loecher, Maureen Ross, Timothy Quinn
Journal: Journal of Clinical Oncology (2023)

e19063 Background: Diffuse alveolar hemorrhage (DAH) is a life-threatening complication seen in patients with malignancy most commonly after a hematopoietic stem cell transplant (HSCT). Systemic therapy with corticosteroids to reduce inflammation and control bleeding is the mainstay of treatment for DAH, however ideal dosing strategies are not known. Methods: This single-center, retrospective study reviewed patients presenting to Roswell Park Comprehensive Cancer Center (RPCCC) from January 2010 through November 2022. Patients were included in this review if they were &gt;18 years and were actively treated at RPCCC for presumed or definite DAH. The bone marrow transplant database, ICD-9, and ICD-10 codes were used to screen patients for inclusion. Upon meeting inclusion criteria, patients were stratified based on daily methylprednisolone dosing equivalents [low-dose: &lt; 250 mg, intermediate-dose: &gt;250 mg or &lt; 1000 mg, high-dose: &gt;1000 mg, or no steroid]. The primary endpoint was 30-day mortality. Secondary endpoints included ICU mortality, ICU length of stay (LOS), overall LOS, hemorrhage recurrence, steroid complications, and utilization of other DAH treatments. Steroid complications, including hyperglycemia, infection, and uremia were evaluated as safety endpoints. Results: Thirty-seven patients met inclusion criteria; 23 HSCT and 14 non-transplant patients. Analysis included 20 patients in the low-dose, 2 patients in the intermediate-dose, 12 patients in the high-dose, and 3 patients in the no steroid group. The median duration of steroids was 15, 4, and 14 days in the low, intermediate, and high groups, respectively. There was no statistically significant difference in 30-day mortality across treatment groups (p = 0.76). The overall 30-day mortality rate was 24.3%, with 25%, 50%, and 17% in the low, intermediate, and high-dose groups, respectively. A 30-day mortality rate of 33% was seen in patients who did not receive steroids. Hemorrhage recurrence occurred in 9 patients (24.3%), most commonly in the high-dose treatment group. Utilization of additional agents including aminocaproic acid, etanercept, and inhaled factor VIIa was most common in the intermediate-dose group. Conclusions: Despite variable steroid dosing, 30-day mortality was not found to be statistically significant among patients treated for DAH. Based on our findings of similar efficacy between dosing strategies, yet increased rates of steroid complications and hemorrhage recurrence in the high-dose group, lower steroid doses for the treatment of DAH can be considered. [Table: see text]
Acupuncture versus massage for pain in patients living with advanced cancer: The IMPACT randomized clinical trial.
Authors: Jun J. Mao, Kevin Liou, Sally A. D. Romero, Raymond E Baser, Greta Wong, Han Xiao, Gary Deng, Zunli Mo, Desiree Walker, Jodi Elizabeth MacLeod, Qing Susan Li, Margaret Barton-Burke, Katherine Panageas, John T Farrar, Andrew S. Epstein
Journal: Journal of Clinical Oncology (2023)

12101 Background: Pain represents a challenging symptom for patients living with advanced cancer and is often associated with fatigue and insomnia. While American Society for Clinical Oncology clinical guidelines recommend acupuncture and massage for oncological pain management, the long-term comparative effectiveness between these two therapies is unknown, particularly among those living with advanced cancer. Methods: We conducted a pragmatic randomized clinical trial to compare acupuncture and massage for musculoskeletal pain among patients living with advanced cancer who experienced at least moderate pain and had a life expectancy of at least six months. Patients received weekly acupuncture or massage treatments for ten weeks, followed by monthly booster sessions up to 26 weeks. The primary endpoint was the change in worst pain intensity score measured by the Brief Pain Inventory (BPI) from baseline to 26 weeks. The secondary outcomes included pain-related interference (BPI), pain medication usage, patient-reported fatigue, insomnia, and quality of life. Analyses were performed using linear mixed models adhering to intent to treat. Results: Among 298 participants (mean age [SD] 58.7 [14.1] years, baseline worst pain 6.6 [1.5], 67.1% women, 25.9% non-white, 15.4% Hispanic, cancer types [21.5% hematologic, 19.8% breast, 14.4% gynecological, and 11.7% gastrointestinal, 9.7% lung, and 9.7% prostate]), 242 (81.2%) completed the primary endpoint. From baseline to week 26, acupuncture reduced worst pain by 2.53 points (95% CI 2.15-2.92) while massage reduced worst pain by 3.01 points (95% CI 2.63-3.38); the between-group difference was not significant (0.48, 95% CI -0.03-0.98, p = 0.066). Both treatments reduced pain-related interference and pain medication usage and improved comorbid fatigue, insomnia, and quality of life to a similar degree without between-group differences. Adverse events were mild: bruising was reported by 9 (6.5%) acupuncture patients, and transient soreness was reported by 21(15.1%) massage patients and 8 (5.8%) acupuncture patients. Despite receiving close in-person treatment, no known COVID-19 transmission was reported between patients and providers. Conclusions: Among patients living with advanced cancer, acupuncture and massage produced similar clinically meaningful improvements in pain and comorbid fatigue and insomnia, decreased use of pain medications, and improved quality of life. Integrating these non-pharmacological therapies into comprehensive cancer care can improve symptom management and quality of life for the ever-growing number of patients living with advanced cancer as a chronic illness. Clinical trial information: NCT04095234 .